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# More Transparency in Advisory Committee Use Needed: Researchers
- URL: https://www.fdaweb.com/more-transparency-in-advisory-committee-use-needed-researchers/
- Published: 2022-05-04T12:00:00.000Z
- Updated: 2026-09-14T17:43:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151739

Harvard University researchers say the percentage of drugs referred for advisory committee review has dropped from 59% in 2011 to 6% in 2021\. Writing in *Health Affairs*, the researchers [say](https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2021.01927?ref=fdaweb.com) meaningful reforms of the advisory committee process could better ensure public trust in an agency decision to allow a drug to come to market, especially if an advisory committee recommended against the drug.

The researchers undertook their study in the wake of the 2021 FDA approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) over the objections of an advisory committee. During the 2011-2021 study period, they write, FDA about once a year approved a drug that has received a negative committee recommendation.

“The questions that FDA poses to advisory committees are not consistent in their wording or substance,” the researchers found. They suggest the agency ask every committee a simple up-or-down approval question for new products as a matter of policy. They also suggest that FDA standardize and publish Frequently Asked Questions that it regularly poses to committee members. “Such simple reforms could support the procedural legitimacy of the drug approval process,” they say.

The study also says the decade-long drop in referrals to advisory committees suggests the agency needs specific criteria for how it chooses to subject new drugs to external scrutiny. “Publishing referral criteria would improve accountability by allowing the public to compare FDA’s referral decisions in individual cases against preexisting standards,” it says.